Nipple Stimulation for Labor Induction

January 16, 2017 updated by: Hadassah Medical Organization

Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures

This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Week 37 + 0 and on
  • PROM (premature rupture of membranes)
  • Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)
  • Not in active labor - without regular contractions fetal monitor, cervical dilation < 4 cm and effacement < 80%.

Exclusion Criteria:

  • Water break > 24 hours at the time of admission to the delivery room
  • Active vaginal bleeding with suspected placental abruption
  • Maternal fever
  • Multifetal pregnancy
  • Women with contraindication for vaginal birth
  • Preeclampsia
  • IUGR (intrauterine growth restriction)
  • Macrosomia
  • Non-reassuring fetal heart tracing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no intervention
Experimental: nipple stimulation
Other: nipple stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression to active labor as measured by the Bishop score
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

December 18, 2016

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • NippleStim-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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